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Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

NCT ID: NCT00831922

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects suffering from active RA who have shown an inadequate response to one DMARD including MTX or anti-TNF, after 3 months (12 weeks) of treatment.

The safety and efficacy will be evaluated on:

Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety Pharmacokinetic profile of AB1010

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis DMARD failure ACR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

masitinib (AB1010) 3 mg/kg/day

Group Type EXPERIMENTAL

masitinib (AB1010)

Intervention Type DRUG

3 mg/kg/day

2

masitinib (AB1010) 6 mg/kg/day

Group Type EXPERIMENTAL

masitinib (AB1010)

Intervention Type DRUG

6 mg/kg/day

Interventions

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masitinib (AB1010)

3 mg/kg/day

Intervention Type DRUG

masitinib (AB1010)

6 mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Meet American College of Rheumatology (ACR) criteria for RA
2. Have active RA
3. ACR functional class I-III
4. Disease onset at \> 16 years of age
5. Disease duration of at least 6 months
6. Failure to one DMARD including methotrexate and anti-TNF alpha

Exclusion Criteria

1. Pregnant or breastfeeding women
2. Inadequate bone marrow function
3. Current use of a DMARD within 4 weeks (or 5 half-lives, whichever is longer) of screening except for leflunomide which requires a specific wash-out
4. Any previous use of recombinant IL1-Ra
5. Current use of more than 1 non steroidal anti-inflammatory drug (NSAID) or change of dose of the NSAID within 4 weeks of baseline or NSAID use greater than the maximum recommended dose
6. Within 4 weeks before baseline, use of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (\>20 mg prednisone or equivalent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Mariette, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Kremlin Bicêtre, France

References

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Tebib J, Mariette X, Bourgeois P, Flipo RM, Gaudin P, Le Loet X, Gineste P, Guy L, Mansfield CD, Moussy A, Dubreuil P, Hermine O, Sibilia J. Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study. Arthritis Res Ther. 2009;11(3):R95. doi: 10.1186/ar2740. Epub 2009 Jun 23.

Reference Type RESULT
PMID: 19549290 (View on PubMed)

Other Identifiers

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AB04012

Identifier Type: -

Identifier Source: org_study_id